The following data is part of a premarket notification filed by Hamilton Medical, Inc. with the FDA for Aladdin Ii Monitoring Oxygen/air Monitor.
| Device ID | K990293 |
| 510k Number | K990293 |
| Device Name: | ALADDIN II MONITORING OXYGEN/AIR MONITOR |
| Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
| Applicant | HAMILTON MEDICAL, INC. 3371 LENORA CHURCH RD. Snellville, GA 30039 |
| Contact | Timothy Y Cowart |
| Correspondent | Timothy Y Cowart HAMILTON MEDICAL, INC. 3371 LENORA CHURCH RD. Snellville, GA 30039 |
| Product Code | BZR |
| CFR Regulation Number | 868.5330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-29 |
| Decision Date | 1999-03-16 |